StrokeCRESNCT05566782
Cross-sectoral Rehabilitation After Stroke (CRES)
An observational study of Stroke and Neurological Rehabilitation, run by Nordsjaellands Hospital at 1 site in Denmark.
Trial summary
Prospective cohort study during post stroke rehabilitation in hospital and municipality. Participants will be measured with accelerometers, tests in relation to physical function and qualitative interviews. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke, Neurological Rehabilitation, Patient Involvement
- How many people
- 117 participants
- Where
- 1 siteDenmark
- Study dates
- 23 Jan 2022to Dec 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Participants will be recruited by the PhD-student Gabriel Tafdrup Notkin (GTN) in collaboration with the Department of Neurology. Potential participants will be approached during admission at the Department of Neurology, NOH. Potential participants will be informed about the study orally and in writing. Patients will be informed that participation is voluntary and that they can withdraw from the study at any time. There will be an opportunity for reflection time and for the patient to discuss the decision to participate with relatives or caregivers. If the patient wishes to participate in the study, written consent will be obtained in the form of a completed consent form from the patient and relatives.
Who may be able to join
- 18 years of age;
- Hospitalized at Nordsjællands Hospital (NOH) with acute stroke;
- Discharged from the Department of Neurology NOH with a general rehabilitation plan to one of the eight surrounding municipalities (Hillerød, Allerød, Gribskov, Helsingør, Hørsholm, Halsnæs, Frederikssund Fredensborg);
- able to give written informed consent;
Who cannot join
- Poor Danish language skill;
- Patients refusing any rehabilitation or medically assessed as inevitably dying within 12 weeks;
Trial locations and contacts
1 site in 1 country.
About this study
Prospective cohort study during post stroke rehabilitation in hospital and municipality. Participants will be measured with accelerometers, tests in relation to physical function and qualitative interviews.
Read the detailed description
During and after hospitalization, patients with stroke are subjected to early rehabilitation starting at the hospital stay and continuing after discharge to a municipality. However, the continuity and adherence across sectors is challenged by different locations for the rehabilitation and time gaps from discharge to start in municipality.
This project focuses on the physical activity of patients with stroke measured with 3D accelerometry, the physical performance of the patients measured using the 30 second Chair Stand Test, balance measured with Bergs Balance Scale and health-related quality of life (HRQoL) measured with the 5-level version of European Quality of Life (EQ5D-5L). Furthermore, the patient perspectives and experiences with the rehabilitation plans are explored in semi-structured interviews at the end of the project.
The municipalities in Nordsjælland have been informed regarding the project and all their approvals have been collected prior to expected start in fall 2022. The heads of rehabilitation in the municipalities have approved participation in the research project with regards to follow-up of patients. The municipalities will support the data collection process with a therapist from each municipality working with quality control of the rehabilitation.
- Conditions
- Stroke, Neurological Rehabilitation, Patient Involvement
- Medical subject headings
- Stroke, Patient Participation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| CRES-participants | The participants in this cohort will start rehabilitation during their inhospital stay and continue the rehabilitation course during discharge to municipality. The rehabilitation will consist of physical exercise and measurements in relation to accelerometry, physical function and qualitative interviews regarding goal for rehabilitation. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Physical activity measured by step counts and intensity minutes during the day (raw acceleration per time cycle)
3D Accelerometers able to capture the daily physical activity performed by the participants in terms of intensity minutes and daily step counts (physiological parameter)
Measured: 10-14 days from hospital discharge til start of rehabilitation in municipality
Change in physical function (30 second chair stand test)
Tests performed during in hospital stay and at discharge and at start/end of rehabilitation
Measured: At four timepoints during rehabilitation. Anticipated days for testing: day 1, day 4, day 11, day 95
Change in balance (Bergs Balance Scale)
Tests performed during in hospital stay and at discharge and at start/end of rehabilitation in municipality. Scores registered in ordinal scale from 0-56 with higher scores indicating lower risk of fall. Bergs Balance Scale consists of 14 test items each with scores ranging from 0, 1, 2, 3 and 4.
Measured: At four timepoints during rehabilitation. Anticipated days for testing: day 1, day 4, day 11, day 95
Change in Health Related Quality of Life (EQ5D-5L)
Measurements with EQ5D-5L send electronically to participants with REDcap system
Measured: Measurement at the start of rehabilitation (day 1) and at the anticipated end of rehabilitation (day 95)
Secondary outcomes (3)
Severity of stroke (Scandinavian Stroke Scale)
Registration from participants medical records. Scores reported in ordinal scale from 0-58 with higher scores indicating less severe impairment form stroke.
Overall categories; mild: 43-58 moderate: 26-42 severe: 0-25
Measured: within 24 hours of admission
Rate of dependence post stroke evaluated by modified Rankin Scale (mRS)
Evaluation performed by primary investigator with participant. Scores in ordinal scale ranging from 0-6 with higher scores indicating worse outcomes post stroke.
Measured: Measurement at the discharge from hospital stay (anticipated day 4)
Demographic variables
age, gender, body mass index, marital status, level of education, employment
Measured: Measurement at the start of rehabilitation (anticipated day 1 of hospital admission)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2022
- Study start23 Jan 2022
- Primary completion5 Oct 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 117 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nordsjaellands Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gabriel Tafdrup Notkin, Nordsjaellands Hospital
- Investigators
- Gabriel T Notkin, MSc.PT., Principal investigator, Physiotherapist, Department of Neurology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05566782
- Sponsor's protocol ID
- CRES&SENS
- Acronym
- CRES
- Status last verified
- Nov 2024
- First submitted
- 26 Sep 2022
- Last updated
- 15 Nov 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cross-sectoral Rehabilitation After Stroke (CRES)
- ClinicalTrials.gov ID
- NCT05566782
- Acronym / sponsor ID
- CRES / CRES&SENS
- Conditions
- Stroke, Neurological Rehabilitation, Patient Involvement
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 117 participants (estimated)
- Lead sponsor
- Nordsjaellands HospitalUniversity, hospital or other
- Study start
- 23 Jan 2022 (actual)
- Primary completion
- 5 Oct 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 4 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Prospective cohort study during post stroke rehabilitation in hospital and municipality. Participants will be measured with accelerometers, tests in relation to physical function and qualitative interviews.
Detailed description
During and after hospitalization, patients with stroke are subjected to early rehabilitation starting at the hospital stay and continuing after discharge to a municipality. However, the continuity and adherence across sectors is challenged by different locations for the rehabilitation and time gaps from discharge to start in municipality.
This project focuses on the physical activity of patients with stroke measured with 3D accelerometry, the physical performance of the patients measured using the 30 second Chair Stand Test, balance measured with Bergs Balance Scale and health-related quality of life (HRQoL) measured with the 5-level version of European Quality of Life (EQ5D-5L). Furthermore, the patient perspectives and experiences with the rehabilitation plans are explored in semi-structured interviews at the end of the project.
The municipalities in Nordsjælland have been informed regarding the project and all their approvals have been collected prior to expected start in fall 2022. The heads of rehabilitation in the municipalities have approved participation in the research project with regards to follow-up of patients. The municipalities will support the data collection process with a therapist from each municipality working with quality control of the rehabilitation.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CRES-participants | – | –The participants in this cohort will start rehabilitation during their inhospital stay and continue the rehabilitation course during discharge to municipality. The rehabilitation will consist of physical exercise and measurements in relation to accelerometry, physical function and qualitative interviews regarding goal for rehabilitation. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Participants will be recruited by the PhD-student Gabriel Tafdrup Notkin (GTN) in collaboration with the Department of Neurology. Potential participants will be approached during admission at the Department of Neurology, NOH. Potential participants will be informed about the study orally and in writing. Patients will be informed that participation is voluntary and that they can withdraw from the study at any time. There will be an opportunity for reflection time and for the patient to discuss the decision to participate with relatives or caregivers. If the patient wishes to participate in the study, written consent will be obtained in the form of a completed consent form from the patient and relatives.
Key inclusion criteria (4 listed)
- 18 years of age;
- Hospitalized at Nordsjællands Hospital (NOH) with acute stroke;
- Discharged from the Department of Neurology NOH with a general rehabilitation plan to one of the eight surrounding municipalities (Hillerød, Allerød, Gribskov, Helsingør, Hørsholm, Halsnæs, Frederikssund Fredensborg);
- able to give written informed consent;
Key exclusion criteria (2 listed)
- Poor Danish language skill;
- Patients refusing any rehabilitation or medically assessed as inevitably dying within 12 weeks;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Physical activity measured by step counts and intensity minutes during the day (raw acceleration per time cycle)
Time frame: 10-14 days from hospital discharge til start of rehabilitation in municipality
3D Accelerometers able to capture the daily physical activity performed by the participants in terms of intensity minutes and daily step counts (physiological parameter)
Change in physical function (30 second chair stand test)
Time frame: At four timepoints during rehabilitation. Anticipated days for testing: day 1, day 4, day 11, day 95
Tests performed during in hospital stay and at discharge and at start/end of rehabilitation
Change in balance (Bergs Balance Scale)
Time frame: At four timepoints during rehabilitation. Anticipated days for testing: day 1, day 4, day 11, day 95
Tests performed during in hospital stay and at discharge and at start/end of rehabilitation in municipality. Scores registered in ordinal scale from 0-56 with higher scores indicating lower risk of fall. Bergs Balance Scale consists of 14 test items each with scores ranging from 0, 1, 2, 3 and 4.
Change in Health Related Quality of Life (EQ5D-5L)
Time frame: Measurement at the start of rehabilitation (day 1) and at the anticipated end of rehabilitation (day 95)
Measurements with EQ5D-5L send electronically to participants with REDcap system
3 secondary outcomes
Severity of stroke (Scandinavian Stroke Scale)
Time frame: within 24 hours of admission
Rate of dependence post stroke evaluated by modified Rankin Scale (mRS)
Time frame: Measurement at the discharge from hospital stay (anticipated day 4)
Demographic variables
Time frame: Measurement at the start of rehabilitation (anticipated day 1 of hospital admission)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Nov 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gabriel T Notkin, MSc.PT. principal investigator
Physiotherapist, Department of Neurology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Stroke and Neurological Rehabilitation, run by Nordsjaellands Hospital at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 15 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Physical activity measured by step counts and intensity minutes during the day (raw acceleration per time cycle) (time frame: 10-14 days from hospital discharge til start of rehabilitation in municipality). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Nov 2024.